Throughout the years the medical field has utilized various techniques to join or bond body tissue together. Historically, suturing was the accepted technique for rejoining severed tissues and closing wounds. Suturing has traditionally been achieved with a surgical needle and a suturing thread, and more recently, with a variety of polymeric or metallic staples. The intended function of sutures is to hold or approximate the edges of a wound or tissue against one another during the healing process so as to reduce discomfort, pain, scarring and the time required for healing. Staples have recently been used to replace suturing when joining or anastomosing various body structures, such as, for example, the bowel. The surgical stapling devices employed to apply these staples are generally designed to simultaneously cut and seal an extended segment of tissue in a patient.
Linear or annular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more rows of surgical fasteners, e. g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of an anastomosis. Linear surgical stapling devices generally include a pair of jaws or finger-like structures between which body tissue to be joined is placed. When the surgical stapling device is actuated and/or “fired,” firing bars move longitudinally and contact staple drive members in one of the jaws, and surgical staples are pushed through the body tissue and into and against an anvil in the opposite jaw thereby crimping the staples closed. A knife blade may be provided to cut between the rows/lines of staples.
Annular surgical stapling devices generally include an annular staple cartridge assembly including a plurality of annular rows of staples (typically two or three), an anvil assembly operatively associated with the annular cartridge assembly, and an annular blade disposed internal of the rows of staples. In general, an end-to-end anastomosis stapler typically places an array or group of staples into the approximated sections of a patient's bowels or other tubular organs. The resulting anastomosis contains an inverted section of bowel which contains numerous “B” shaped staples to maintain a secure connection between the approximated sections of bowel.
Anastomotic leaks may result in morbidity and frequently death. In addition to the use of surgical staples, sealants, e. g., synthetic or biological sealants, can be applied to the surgical site to guard against leakage. The biological sealants are typically applied to the outer surface of the anastomosis using a dual lumen syringe or spray nozzle in a separate step. The delivery of the sealant can be compromised by an inability to get at or between individual staple sites, and along staple lines and tissue seams.
U.S. Pat. No. 7,793,813 titled “Hub for positioning annular structure on a surgical device” discloses an assembly for disposing an annular structure between adjacent intestinal sections, the assembly comprising: a) an annular surgical stapling device having an anvil assembly and a tubular body portion, the anvil assembly having an anvil member and an anvil shaft, the tubular body portion carrying a plurality of surgical staples in an annular configuration, the tubular body portion having a connection member disposed radially inward of the surgical staples, the anvil shaft of the anvil member including a flange and being attachable to the connection member of the tubular body portion; and b) a hub adapted for support on the anvil shaft to engage the flange of the anvil shaft, the hub including a central sleeve defining a lumen therethrough for selectively receiving the anvil shaft therein, and an annular structure radially extending from the central sleeve, the annular structure including an outer annular disc defining a central opening having a dimension larger than an outer diameter of the central sleeve and a web interconnecting the disc to the central sleeve, wherein the central sleeve comprises at least one resilient finger extending substantially in a longitudinal direction, and wherein, when the hub is supported on the anvil shaft, the at least one resilient finger engages the flange of the anvil shaft to position the annular structure at a location spaced a distance from a tissue contacting surface of each of the anvil assembly and the tubular body portion.
U.S. Pat. No. 9,161,757 titled “Hub for positioning annular structure on a surgical device” discloses a method of disposing an annular structure between adjacent tissue sections, the method comprising the steps of: a) providing a surgical stapling device including an anvil assembly and a body portion, the anvil assembly including an anvil member supported on an anvil shaft and the body portion carrying a plurality of surgical staples and a knife; b) providing a hub for locating an annular structure between the adjacent tissue sections, the hub including a central sleeve having a first end and a second end defining a lumen therebetween, the central sleeve configured to selectively receive and engage the anvil shaft of the anvil assembly, and an annular structure extending from the first end of the central sleeve and extending radially outwardly therefrom; c) inserting the anvil assembly into a first tissue section such that the anvil member is positioned adjacent to a first side of the first tissue section; d) after the anvil assembly is inserted into the first tissue section, positioning the hub onto the anvil shaft by inserting the anvil shaft through the first end of the hub and towards the second end of the hub such that the annular structure is concentrically located with respect to a longitudinal axis of the anvil shaft and such that the annular structure is positioned immediately adjacent to a second side of the first tissue section that is opposed to the first side of the first tissue section; e) inserting the body portion into a second tissue section; f) approximating the anvil assembly, hub and body portion with one another so that an end portion of the first tissue section, an end portion of the second tissue section and the annular structure are disposed between the anvil member and the body portion; and g) connecting the anvil assembly to the surgical stapling device so that a proximal end of the anvil shaft is connected to a connection member mounted within the body portion of the surgical stapling device, wherein the annular structure is disposed between the first tissue section and the second tissue section.
U.S. Pat. No. 7,128,748 titled “Circular stapler buttress combination” discloses a combination medical device comprising: a) a circular stapler instrument, comprising a staple cartridge component having a central recessed aperture and corresponding anvil component having a central recessed aperture, and b) one or more portions of buttress material adapted to be a) stably positioned upon the staple cartridge and/or anvil components of the stapler instrument prior to, or at the time of, use, b) while in position upon the stapler instrument component(s), to then be delivered to a tissue site in combination with the stapler instrument components, c) upon delivery of the components and positioned material portion(s) to the tissue site, to provide a first region of buttress material as a staple line buttress seal between joined tissue sections upon activation of the stapler instrument, and optionally, d) to permit the removal of one or more portions of a second region of the buttress material upon activation of a stapler instrument knife provided by the stapler instrument, wherein the buttress material portion adapted to fit the cartridge component comprises a circumferential disc having an integral raised center portion adapted to fit the central recessed aperture of the cartridge, and the buttress material portion adapted to fit the anvil component comprises a circumferential disc having an integral raised center portion adapted to fit the central recessed aperture of the anvil.
U. S. Patent Application publication No. 2014/0097224 titled “Buttress Fixation for a Circular Stapler” discloses a circular stapling apparatus, comprising: an anvil assembly with an anvil member and a shaft; a tubular body portion having a staple cartridge, the shaft of the anvil assembly being connectable to the tubular body portion so that the anvil assembly is movable toward and away from the tubular body portion, the staple cartridge including a plurality of staple and a pusher having a fingers for driving the staples, at least one of the fingers including a protrusion; a buttress material removably attached to the anvil assembly, staple cartridge, or both, by at least one anchor; and at least one of the anvil assembly and staple cartridge having a notch shaped for retaining the anchor, the pusher being movable to move the protrusion into engagement with the anchor in the notch.
U. S. Patent Application publication No. 2014/0197224 titled “Buttress retainer for EEA anvil” discloses an apparatus for joining two hollow organ sections with an annular array of surgical staples, the apparatus comprising: a staple cartridge assembly including a plurality of surgical staples in an annular array; an anvil assembly including an anvil member and a shaft extending therefrom, the anvil member including a proximal surface defining a plurality of staple pockets for deforming the surgical staples, the anvil assembly movable relative to the staple cartridge assembly between spaced apart and approximated positions to adjustably clamp tissue between the staple cartridge and anvil assemblies; and a buttress assembly including: a ring member configured to engage a knife member, the ring member secured with the anvil member; a buttress member disposed in a superposed relation with the plurality of staple pockets defined in the anvil member; and a retaining member having an attaching member configured to be secured with the ring member to secure the buttress member between the cut ring and the retaining member, and to position the buttress member relative to the anvil assembly.
U.S. Pat. No. 9,010,612 titled “Buttress support design for EEA anvil” discloses an apparatus for joining two hollow organ sections with an annular array of surgical staples, the apparatus comprising: a staple cartridge component including a plurality of surgical staples in the annular array; an anvil component including an anvil member and a shaft extending therefrom, the anvil member defining a plurality of staple pockets for deforming the plurality of surgical staples, the anvil component movable relative to the staple cartridge component between spaced apart and approximated positions to adjustably clamp tissue between the staple cartridge and anvil components; a buttress member concentrically aligned with the plurality of staple pockets defined in the anvil member; and a buttress mount detachably secured with the shaft of the anvil component, the buttress mount including an annular ring member and at least one support member radially extending outward from the annular ring member to secure the buttress member to the anvil member, the at least one support member at least partially underlying the buttress member to provide support thereto, wherein the buttress mount is separate from the buttress member, and the annular ring member of the buttress mount is secured to the shaft of the anvil component.
U. S. Patent Application publication No. 2014/0217147 titled “Circular Stapling Device Including Buttress Material” discloses a circular stapling device, comprising: a handle assembly; an elongate body that extends from the handle assembly; an end effector mounted on a distal end of the elongate body and including a cartridge assembly and an anvil assembly, the anvil assembly including: a circular anvil head that supports a crush ring; an anvil cap that connects to the anvil head, the anvil cap being movable relative to the anvil head between an approximated position and an unapproximated position, the crush ring being spaced from the anvil cap when the anvil cap is disposed in the approximated position and movable into engagement with the anvil cap to move the anvil cap to the unapproximated position, the anvil cap supporting an O-ring; and a circular anvil buttress member including a body portion and an extension portion that extends from the body portion, the body portion supported on a tissue engaging surface of the anvil head, the extension portion being securable between the O-ring and the anvil head when the anvil cap is disposed in the approximated position, the extension portion being releasable from between the O-ring and the anvil head when the anvil cap is disposed in the unapproximated position so that the body portion separates from the tissue engaging surface of the anvil head.
European Patent Application publication No. 2,620,107A1 titled “Surgical device including buttress material” discloses a surgical stapling device for joining tissue portions, comprising: a handle assembly; a tubular body portion supported on a distal end of the handle assembly, the tubular body portion having a staple cartridge assembly containing a plurality of surgical staples in an annular array; an anvil assembly at a distal end of the stapling device, the anvil assembly having a shaft for removably connecting the anvil assembly to the tubular body portion, the anvil assembly and tubular body portion being juxtaposed with respect to one another along the shaft and arranged so as to be approximated with respect to one another; a support member extending from the tubular body portion towards the anvil assembly; and a buttress material supported by the support member and removably attached thereto, the buttress material being disposed between the anvil assembly and the staple cartridge assembly.
U.S. Pat. No. 8,967,448 titled “Surgical stapling apparatus including buttress attachment via tabs” discloses an apparatus for joining two hollow organ sections with an annular array of surgical staples, the apparatus comprising: a staple cartridge component including a plurality of surgical staples arranged in an annular array, the staple cartridge component including an outer wall defining a circumferential groove therein; an anvil component movable relative to the staple cartridge component between spaced apart and approximated positions to adjustably clamp the organ sections between the staple cartridge and anvil components; a buttress component configured and dimensioned to be positioned on a distal surface of the staple cartridge component, the buttress component including a buttress member and a plurality of circumferentially arranged tabs extending proximally from the buttress member, each tab having a length such that the tab extends across the circumferential groove of the staple cartridge component when the buttress member overlies a tissue facing surface of the staple cartridge component; and a fastening member configured and dimensioned to engage the plurality of circumferentially arranged tabs into the circumferential groove of the staple cartridge component to securely position the buttress component on the staple cartridge component.
U. S. Patent Application publication No. 2013/0068819 entitled “Structure Containing Wound Treatment Material”, discloses an anvil assembly for a circular stapling apparatus, where the anvil assembly includes an anvil head configured to support an anvil plate thereon; a shaft extending from the anvil head and configured to selectively engage a connection member of the circular stapling apparatus; an anvil plate operatively connected to the anvil head, the anvil plate defining a plurality of staple forming pockets therein; and a wound treatment material disposed in each staple forming pocket of the anvil plate. The wound treatment material is at least one of an adhesive, a sealant, a hemostat and a medicament.
U.S. Pat. No. 8,152,042 entitled “Annular Adhesive Structure” discloses an apparatus for sealing at the anastomotic site. In some embodiments, a washer or structural body is wrapped completely around an anvil shaft, with staples driven through the structural body to release the sealant.
Post-operative leakage of the anastomotic seals has been shown in some instances to lead to morbidity and mortality. A number of technologies are intended to address leakage by reinforcing the tissue using a buttress or a similar reinforcing structure applied to the tissue being joined. However there is a lack of reliable and rapid technique for installation of the buttress and fixation of the buttress immediately prior to stapling tissues and establishment of the anastomotic joint, due to the difficult access to the site and also due to the need to have the devices and methods applicable to a wide variety of anastomotic staplers available to the surgeon. Alternative methods to fixate the buttress by adhesives or retention rings are complex and may result in unreliable separation of the buttress from the anvil. The insertion of the anvil into the tubular tissue remains challenging since the tissue mucosal walls tend to separate the buttress from the anvil surface during insertion. There is a need for devices enabling properly positioning and retaining a buttress prior to anastomotic stapling.